Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

NCT03162250 — Phase 1, Completed, 27 participants, Genentech, Inc.

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A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care Antibiotics

Registry	NCT03162250
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	27 (Actual)
Sponsor	Genentech, Inc. (Industry)
Conditions	Bacteremia
Interventions	DSTA4637S, Placebo, SOC (Drug)
Dates	start 2017-07-13, primary completion 2020-01-15, completion 2020-01-15, first posted 2017-05-22, last updated 2020-01-22
Locations	16 sites in United States, South Korea, Spain

-Summary

This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.

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+Arms and interventions

Arm	Type	Interventions	Description
DSTA4637S low dose level + SOC	Experimental	Drug: DSTA4637S; Drug: SOC	DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
DSTA4637S intermediate dose level+ SOC	Experimental	Drug: DSTA4637S; Drug: SOC	DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
DSTA4637S high dose level+ SOC	Experimental	Drug: DSTA4637S; Drug: SOC	DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
Placebo + SOC	Placebo comparator	Drug: Placebo; Drug: SOC	Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.

DSTA4637S (Drug): DSTA4637S will be administered as an IV infusion at 3 dose levels.
Placebo (Drug): Placebo matched to DSTA4637S IV infusion will be administered as specified.
SOC (Drug): Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.

+Outcome measures

Primary outcomes

Percentage of Participants With Adverse Events (AEs) [Baseline up to approximately 156 Days]

Secondary outcomes

Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma [Baseline up to approximately 156 Days]
Measure of DSTA4637S Total Antibody measured by Serum [Baseline up to approximately 156 Days]
Measure of Unconjugated dmDNA31 measured by Plasma [Baseline up to approximately 156 Days]
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S [Baseline up to approximately 156 Days]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Body mass index greater than or equal (>/=) 18 to less than or equal to (</=) 40 kg/m\^2
* At randomization, participants must have >/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours
* In the investigator's judgment, an expected treatment duration for S. aureus intravenous infection with anti-staphylococcal SOC antibiotics >/= 4 weeks

Exclusion Criteria:

* The presence of an intravascular catheter that is not planned to be removed within 96 hours of study randomization
* S. aureus bacteremia associated with an intracardiac device and/or intravascular prosthetic material (including hemodialysis access graft)
* In the investigator's judgement, S. aureus bacteremia involving infection of a prosthetic joint or vertebral hardware
* In participants with cirrhosis, a Child-Pugh Score of Class B or C
* Known rifampicin-resistant S. aureus
* Anticipated receipt of a rifamycin class (excluding rifaxamin) antibiotic from Day 1 to study completion/discontinuation
* In the investigator's judgment, the need for emergent valve surgery at the time of randomization or a high likelihood of cardiac surgery within 3 days after randomization
* Polymicrobial bacteremia
* Participants with significant immune suppression
* Participants with evidence of liver disease
* History or presence of an abnormal electrocardiogram (ECG)
* Exposure to any biological therapy or investigational biological agent within 90 days prior to the screening evaluation or have received any other investigational treatment 30 days prior to the screening evaluation

+Locations (16)

Facility	City	Country
Los Angeles Biomedical Research Institute at Harbor-UCLA	Torrance, California	United States
Henry Ford Health System	Detroit, Michigan	United States
William Beaumont Hospital	Royal Oak, Michigan	United States
Duke University Medical Center	Durham, North Carolina	United States
Chungnam National University Hospital	Daejeon	South Korea
Gyeongsang National University Hospital	Gyeongsangnam-do	South Korea
Asan Medical Center - Oncology	Seoul	South Korea
Korea University Guro Hospital	Seoul	South Korea
Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat, Barcelona	Spain
Hospital Mutua de Terrassa	Terrassa, Barcelona	Spain
Hospital Universitario Marques de Valdecilla	Santander, Cantabria	Spain
Hospital del Mar	Barcelona	Spain
Hospital Clinic de Barcelona	Barcelona	Spain
Hospital Universitario Ramon y Cajal	Madrid	Spain
Hospital Universitario Virgen Macarena	Seville	Spain
Hospital Universitario Virgen del Rocio	Seville	Spain

+Funding

NIH grants: 2016

My Notes

Public

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